Biomarker Insights最新文献

{"title":"The Use of Biomarkers in Pharmacovigilance: A Systematic Review of the Literature.","authors":"Maribel Salas, Maxine Gossell-Williams, Priyanka Yalamanchili, Sameer Dhingra, Marina A Malikova, Omar Aimer, Toluwalope Junaid","doi":"10.1177/11772719231164528","DOIUrl":"https://doi.org/10.1177/11772719231164528","url":null,"abstract":"Background The use of biomarkers varies from disease etiognosis and diagnosis to signal detection, risk prediction, and management. Biomarker use has expanded in recent years, however, there are limited reviews on the use of biomarkers in pharmacovigilance and specifically in the monitoring and management of adverse drug reactions (ADRs). Objective The objective of this manuscript is to identify the multiple uses of biomarkers in pharmacovigilance irrespective of the therapeutic area. Design This is a systematic review of the literature. Data Sources and Methods Embase and MEDLINE database searches were conducted for literature published between 2010-March 19, 2021. Scientific articles that described the potential use of biomarkers in pharmacovigilance in sufficient detail were reviewed. Papers that did not fulfill the United States Food and Drug Administration (US FDA) definition of a biomarker were excluded, which is based on the International Conference on Harmonisation (ICH)-E16 guidance. Results Twenty-seven articles were identified for evaluation. Most articles involved predictive biomarkers (41%), followed by safety biomarkers (38%), pharmacodynamic/response biomarkers (14%), and diagnostic biomarkers (7%). Some articles described biomarkers that applied to multiple categories. Conclusion Various categories of biomarkers including safety, predictive, pharmacodynamic/response, and diagnostic biomarkers are being investigated for potential use in pharmacovigilance. The most frequent potential uses of biomarkers in pharmacovigilance in the literature were the prediction of the severity of an ADR, mortality, response, safety, and toxicity. The safety biomarkers identified were used to evaluate patient safety during dose escalation, identify patients who may benefit from further biomarker testing during treatment, and monitor ADRs.","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231164528"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4b/0e/10.1177_11772719231164528.PMC10108426.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9738493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Caveat Medicus: It's Time to Re-Think Stratification, You May Not Be Helping.","authors":"Ognjen Arandjelović","doi":"10.1177/11772719231174746","DOIUrl":"https://doi.org/10.1177/11772719231174746","url":null,"abstract":"<p><strong>Background: </strong>The focus of the present Letter is on the large and seemingly fertile body of work captured under the umbrella of 'patient stratification'.</p><p><strong>Objectives: </strong>I identify and explain a fundamental methodological flaw underlying the manner in which the development of an increasingly large number of new stratification strategies is approached.</p><p><strong>Design: </strong>I show an inherent conflict between the assumptions made, and the very purpose of stratification and its application in practice.</p><p><strong>Methods: </strong>I analyse the methodological underpinnings of stratification as presently done and draw parallels with conceptually similarly flawed precedents which are now widely recognized.</p><p><strong>Results: </strong>The highlighted flaw is shown to undermine the overarching ultimate goal of improved patient outcomes by undue fixation on an ill-founded proxy.</p><p><strong>Conclusion: </strong>I issue a call for a re-think of the problem and the processes leading to the adoption of new stratification strategies in the clinic.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231174746"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10186568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9495459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of Prognostic Club Cell Secretory Protein (CC16) Cut-point in an Independent ALTA Cohort.","authors":"Sultan Almuntashiri,&nbsp;Aaron Chase,&nbsp;Andrea Sikora,&nbsp;Duo Zhang","doi":"10.1177/11772719231156308","DOIUrl":"https://doi.org/10.1177/11772719231156308","url":null,"abstract":"<p><strong>Background: </strong>Club cell secretory protein (CC16) has demonstrated utility as a lung-specific biomarker in predicting mortality in acute respiratory distress syndrome (ARDS). These findings have been observed in pre-clinical trials and a re-analysis of a large, randomized controlled trial of ARDS (Fluid and Catheter Treatment Trial (FACTT)).</p><p><strong>Objectives: </strong>The purpose of this study was to validate previous findings by evaluating CC16 level as a mortality predictor in patients from the albuterol to treat acute lung injury (ALTA) trial.</p><p><strong>Design and method: </strong>In this secondary biomarker analysis, plasma CC16 level was measured from 100 ALTA subjects using enzyme-linked immunosorbent assay (ELISA). The rate of mortality was assessed in patients with high (⩾45 ng/mL) versus low CC16 (<45 ng/mL) levels. This cut-off level was applied based on our previous analysis from FACTT trial. Significance was assessed using Kaplan-Meier curves and a log-rank test.</p><p><strong>Results: </strong>Subjects were an average of 50 years old and 46% of them were females. Patients with high CC16 levels had higher 90-day mortality compared to those with low CC16 levels, (37.73% vs 8.95%, <i>P</i> < .001). Other clinical outcomes including ICU-free days, ventilator-free days, and organ failure free days were significantly different between the groups (All <i>P</i> < .05).</p><p><strong>Conclusion: </strong>In this validation study, we demonstrated that ARDS patients with high plasma CC16 concentration had a higher mortality rate than those with low CC16 levels, confirming previous findings that CC16 levels are associated with ARDS mortality.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231156308"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4b/71/10.1177_11772719231156308.PMC9940244.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9088963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is the Diagnostic Accuracy of Novel Urine Biomarkers for Urinary Tract Infection?","authors":"George Edwards,&nbsp;Anna Seeley,&nbsp;Adam Carter,&nbsp;Maia Patrick Smith,&nbsp;Elizabeth LA Cross,&nbsp;Kathryn Hughes,&nbsp;Ann Van den Bruel,&nbsp;Martin J Llewelyn,&nbsp;Jan Y Verbakel,&nbsp;Gail Hayward","doi":"10.1177/11772719221144459","DOIUrl":"https://doi.org/10.1177/11772719221144459","url":null,"abstract":"<p><strong>Background: </strong>Urinary tract infection (UTI) affects half of women at least once in their lifetime. Current diagnosis involves urinary dipstick and urine culture, yet both methods have modest diagnostic accuracy, and cannot support decision-making in patient populations with high prevalence of asymptomatic bacteriuria, such as older adults. Detecting biomarkers of host response in the urine of hosts has the potential to improve diagnosis.</p><p><strong>Objectives: </strong>To synthesise the evidence of the diagnostic accuracy of novel biomarkers for UTI, and of their ability to differentiate UTI from asymptomatic bacteriuria.</p><p><strong>Design: </strong>A systematic review.</p><p><strong>Data sources and methods: </strong>We searched MEDLINE, EMBASE, CINAHL and Web of Science for studies of novel biomarkers for the diagnosis of UTI. We excluded studies assessing biomarkers included in urine dipsticks as these have been well described previously. We included studies of adult patients (≥16 years) with a suspected or confirmed urinary tract infection using microscopy and culture as the reference standard. We excluded studies using clinical signs and symptoms, or urine dipstick only as a reference standard. Quality appraisal was performed using QUADAS-2. We summarised our data using point estimates and data accuracy statistics.</p><p><strong>Results: </strong>We included 37 studies on 4009 adults measuring 66 biomarkers. Study quality was limited by case-control design and study size; only 4 included studies had a prospective cohort design. IL-6 and IL-8 were the most studied biomarkers. We found plausible evidence to suggest that IL-8, IL-6, GRO-a, sTNF-1, sTNF-2 and MCR may benefit from more rigorous evaluation of their potential diagnostic value for UTI.</p><p><strong>Conclusions: </strong>There is insufficient evidence to recommend the use of any novel biomarker for UTI diagnosis at present. Further evaluation of the more promising candidates, is needed before they can be recommended for clinical use.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719221144459"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9902898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10679738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Copeptin Reflect Left Ventricular Systolic Function at Early Stage of Acute Myocardial Infarction in a Pig Model.","authors":"Wenjia Li,&nbsp;Wenjian Sun,&nbsp;Liang Lyu,&nbsp;Gang Wang,&nbsp;Weixin Yang,&nbsp;Hongfei An,&nbsp;Liling Chen,&nbsp;Jianhui Fan,&nbsp;Yan Yue,&nbsp;Rongshun Zhang","doi":"10.1177/11772719231171764","DOIUrl":"https://doi.org/10.1177/11772719231171764","url":null,"abstract":"<p><strong>Introduction: </strong>Measurement of biomarkers early after acute myocardial infarction (AMI) might provide a cost-effective and widely available tool to assess infarct severity, myocardial dysfunction, and clinical outcomes. We aimed to induce AMI in miniature pigs, measure the levels of serum biomarkers and global LV function dynamically and explore the release kinetics and optimal sampling time points of copeptin and its correlation with global LV function.</p><p><strong>Methods: </strong>We induced AMI in the experimental group using a closed-chest model. Left ventricular (LV) function was detected by dual-source computed tomography (DSCT) and serum copeptin was determined by ELISA.</p><p><strong>Results: </strong>The serum copeptin levels were increased at 1 hour, peaked at 3 hours, gradually decreased after 6 hours, and returned to baseline 3 days after AMI. At 3 to 6 hours, the copeptin cutoff of 16.97 to 17.44 pmol/l had 100% sensitivity and 100% specificity (<i>P</i> ⩽ .001) for AMI. Serum copeptin levels at 3 hours and 3 days were negatively correlated with the 3-hours LVEF (<i>P</i> ⩽ .001), respectively.</p><p><strong>Conclusion: </strong>Serum copeptin levels change in time, and measurements at 3 to 6 hours after AMI had the highest predictive value.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231171764"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/02/e7/10.1177_11772719231171764.PMC10155031.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10289659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of a Customized Tertiary Analysis Platform for the Reporting of Somatic Variants.","authors":"Kala F Schilter,&nbsp;Sarah Dubay,&nbsp;Matt Stachowiak,&nbsp;Alysia Kaplan,&nbsp;Abby Stauffenger,&nbsp;Honey V Reddi","doi":"10.1177/11772719231178618","DOIUrl":"https://doi.org/10.1177/11772719231178618","url":null,"abstract":"<p><p>Precision medicine for oncology requires the evaluation of variants identified in molecular profiling of solid tumors and hematologic malignancies. This includes evaluation of pre-analytical and postanalytical quality metrics, variant interpretation, classification, and tiering as outlined in established guidelines, association with clinical significance such as FDA approved drugs and clinical trials, and finally comprehensive reporting. This study documents our experience with the customization and implementation of a software platform that facilitates these requirements for effective reporting of somatic variants.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":"18 ","pages":"11772719231178618"},"PeriodicalIF":3.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/63/ba/10.1177_11772719231178618.PMC10259170.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9686203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Genetic Polymorphisms of the Antioxidant Enzymes and Biomarkers of Oxidative Stress in Preterm Neonates With Respiratory Distress Syndrome Receiving External Surfactant.","authors":"Kannan Sridharan,&nbsp;Mona Al Jufairi,&nbsp;Aamal AbdulGhani Mahdi Hejab,&nbsp;Abdulraoof Al Madhoob,&nbsp;Reem Al Marzooq,&nbsp;Safa Taha,&nbsp;Muna Jaber Mulla Aljishi,&nbsp;Ameera Abdulhadi,&nbsp;Eman Al Ansari,&nbsp;Masooma Abdulla Ali,&nbsp;Maryam Ali Ahmed Naser,&nbsp;Ola Al Segai,&nbsp;Kevin Dunne","doi":"10.1177/11772719221137608","DOIUrl":"https://doi.org/10.1177/11772719221137608","url":null,"abstract":"<p><strong>Background: </strong>Preterm neonates, particularly extremely preterm, are susceptible to respiratory distress syndrome (RDS) due to surfactant deficiency. Single nucleotide polymorphisms (SNPs) in the antioxidant enzymes influence the balance between antioxidant and oxidative stress molecules.</p><p><strong>Objectives: </strong>To ascertain the role of SNPs of antioxidant enzymes and oxidative stress biomarkers in preterm neonates with RDS.</p><p><strong>Design: </strong>Observational, cross-sectional study.</p><p><strong>Methods: </strong>Preterm neonates diagnosed with RDS receiving external surfactant within 24 hours were considered as the cases and those without RDS were the control group. Umbilical cord blood and peripheral blood samples before administering surfactant (day 1), and on days 2 and 3 were collected. Plasma malondialdehyde, 8-hydroxy-2-deoxy guanosine (8-OH-dG), advanced oxidation protein products (AOPP), total antioxidant capacity (TAC), visfatin, reduced glutathione, and chaperonin 60 were evaluated using enzyme-linked immunosorbent assay. SNPs in manganese superoxide dismutase (MnSOD), copper/zinc superoxide dismutase (Cu/Zn SOD), glutathione peroxidase (GPX1 and GPX3), catalase (CAT), glutathione S-transferase (GSTP1) were evaluated using real-time polymerase-chain-reaction. The receiver-operating characteristics curve was used for predicting the accuracy of biomarkers using the area under the curve (AUC) and 95% confidence intervals (95% CI).</p><p><strong>Results: </strong>GSTP1, MnSOD, and eNOS (rs1799983) SNPs were observed to significantly influence the oxidative biomarker concentrations in the entire study population. SNPs in <i>GSTP1</i>, <i>MnSOD</i>, and <i>eNOS</i> (rs1799983) were significantly associated with differences in oxidative stress biomarkers. <i>MnSOD</i> (rs4880) significantly increased the risk of pulmonary complications in neonates with RDS. DNA damage product (8-OH-dG) concentrations before surfactant administration has the best predictive accuracy (AUC: 0.8; 95% CI: 0.7-1; <i>P</i> = .001) for pulmonary complications with a cut-off value of 5008.8 pg/mL. TAC concentrations are significantly greater on day 2 and day 3 amongst neonates receiving surfactant compared to the control group. AOPP in the umbilical cord blood was observed to significantly predict the severity of RDS (AUC: 0.8; 95% CI: 0.6-1; <i>P</i> = .01) with an optimal cut-off value of 88.78 µmol/L.</p><p><strong>Conclusion: </strong>We observed that SNPs in <i>eNOS</i> and <i>MnSOD</i> significantly influence the production of oxidative stress biomarkers in preterm neonates. Baseline 8-OH-dG concentrations best predict the risk of pulmonary complications and AOPP concentrations in the umbilical cord blood predict the risk of RDS severity.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":" ","pages":"11772719221137608"},"PeriodicalIF":3.8,"publicationDate":"2022-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ab/52/10.1177_11772719221137608.PMC9663612.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40689826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Prognostic Value of Lung Injury and Fibrosis Markers, KL-6, TGF-β1, FGF-2 in COVID-19 Patients.","authors":"Hazan Karadeniz,&nbsp;Aslıhan Avanoğlu Güler,&nbsp;Hasan Selçuk Özger,&nbsp;Pınar Aysert Yıldız,&nbsp;Gonca Erbaş,&nbsp;Gülendam Bozdayı,&nbsp;Tuba Deveci Bulut,&nbsp;Özlem Gülbahar,&nbsp;Dilek Yapar,&nbsp;Hamit Küçük,&nbsp;Mehmet Akif Öztürk,&nbsp;Abdurrahman Tufan","doi":"10.1177/11772719221135443","DOIUrl":"https://doi.org/10.1177/11772719221135443","url":null,"abstract":"<p><strong>Background: </strong>Biomarkers of lung injury and interstitial fibrosis give insight about the extent of involvement and prognosis in well-known interstitial lung diseases (ILD). Serum Krebs von den Lungen-6 (KL-6) reflects direct alveolar injury and, transforming growth factor-beta1 (TGF-β1) and fibroblast growth factor-2 (FGF-2) are principal mediators of fibrosis in ILD and in almost all fibrotic diseases. In this sense, we aimed to assess associations of these biomarkers with traditional inflammatory markers and clinical course of COVID-19.</p><p><strong>Methods: </strong>Patients with COVID-19 who had confirmed diagnosis with SARS-CoV-2 nucleic acid RT-PCR were enrolled and followed up prospectively with a standardized approach one month after diagnosis. Patients were divided into severe and non-severe groups according to National Institutes of Health criteria. Outcome was assessed for the requirement of intensive care unit (ICU) admission, long term respiratory support and death. Blood samples were collected at enrollment and serum levels of KL-6, TGF-β1, FGF-2 were determined by ELISA. Association between these markers with other prognostic markers and prognosis were analyzed.</p><p><strong>Results: </strong>Overall 31 severe and 28 non-severe COVID-19 patients were enrolled and were compared with healthy control subjects (n = 30). Serum KL-6 levels in COVID-19 patients were significantly higher (median [IQR]; 11.54 [4.86] vs 8.54 [3.98] ng/mL, <i>P</i> = .001] and FGF-2 levels were lower (median [IQR]; 76.84 [98.2] vs 101.62 [210.6] pg/mL) compared to healthy control group. A significant correlation was found between KL-6 values and CRP, fibrinogen, d-dimer and lymphocyte counts. However, we did not find an association between these markers and subsequent severity of COVID-19, mortality and long-term prognosis.</p><p><strong>Conclusions: </strong>Serum KL-6 levels were significantly elevated at the diagnosis of COVID-19 and correlated well with the other traditional prognostic inflammatory markers. Serum levels of principal fibrosis mediators, TGF-β1, FGF-2, were not elevated at diagnosis of COVID-19, therefore did not help to anticipate long term prognosis.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":" ","pages":"11772719221135443"},"PeriodicalIF":3.8,"publicationDate":"2022-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6f/6c/10.1177_11772719221135443.PMC9643117.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40687245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monitoring of Post-Brain Injuries By Measuring Plasma Levels of Neuron-Derived Extracellular Vesicles.","authors":"Naoshi Hotta,&nbsp;Takahiro Tadokoro,&nbsp;John Henry,&nbsp;Daisuke Koga,&nbsp;Keisuke Kawata,&nbsp;Hiroyuki Ishida,&nbsp;Yuko Oguma,&nbsp;Akihiro Hirata,&nbsp;Masato Mitsuhashi,&nbsp;Kenji Yoshitani","doi":"10.1177/11772719221128145","DOIUrl":"https://doi.org/10.1177/11772719221128145","url":null,"abstract":"<p><strong>Background: </strong>Extracellular vesicles (EV) released from neurons into the blood can reflect the state of nervous tissue. Measurement of neuron derived EV (NDE) may serve as an indicator of brain injury.</p><p><strong>Methods: </strong>A sandwich immunoassay was established to measure plasma NDE using anti-neuron CD171 and anti-EV CD9 ([CD171 ⁺ CD9⁺]). Plasma samples were obtained from commercial sources, cross-country (n = 9), football (n = 22), soccer (n = 19), and rugby (n = 18) athletes over time. Plasma was also collected from patients undergoing total aortic arch replacement (TAR) with selective cerebral perfusion during cardiopulmonary bypass before and after surgery (n = 36).</p><p><strong>Results: </strong>The specificity, linearity, and reproducibility of NDE assay (measurement of [CD171 ⁺ CD9⁺]) were confirmed. By scanning electron microscopy and nanoparticle tracking, spherical vesicles ranging in size from 150 to 300 nm were confirmed. Plasma levels of NDE were widely spread over 2 to 3 logs in different individuals with a significant age-dependent decrease. However, NDE were very stable in each individual within <i>a</i> ± 50% change over time (cross-country, football, soccer), whereas rugby players were more variable over 4 years. In patients undergoing TAR, NDE increased rapidly in days post-surgery and were significantly (<i>P</i> = .0004) higher in those developing postoperative delirium (POD) (n = 13) than non-delirium patients (n = 23).</p><p><strong>Conclusions: </strong>The blood test to determine plasma levels of NDE was established by a sandwich immunoassay using 2 antibodies against neuron (CD171) and exosomes (CD9). NDE levels varied widely in different individuals and decreased with age, indicating that NDE levels should be considered as a normalizer of NDE biomarker studies. However, NDE levels were stable over time in each individual, and increased rapidly after TAR with greater increases associated with patients developing POD. This assay may serve as a surrogate for evaluating and monitoring brain injuries.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":" ","pages":"11772719221128145"},"PeriodicalIF":3.8,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0f/53/10.1177_11772719221128145.PMC9618756.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40662051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Behaviour of Serum Survivin in Patients With Lupus Nephritis.","authors":"Renata Valente Lisboa,&nbsp;Fabiola Reis de Oliveira,&nbsp;Thaise Oliveira Quaresma,&nbsp;Rafael Moura de Almeida,&nbsp;Rene Donizeti Ribeiro Oliveira,&nbsp;Paulo Louzada Junior","doi":"10.1177/11772719221131470","DOIUrl":"https://doi.org/10.1177/11772719221131470","url":null,"abstract":"<p><strong>Background: </strong>Systemic lupus erythematosus (SLE) is a chronic, multi phenotypic, autoimmune inflammatory disease and renal involvement significantly worsens its prognosis. Apoptosis dysregulation plays a key pathogenic role. Survivin, a protein from the apoptosis inhibitors family, has been considered a promising strategy in cancer therapy and evaluated as one of the regulatory pathways in the scenario of immune-mediated disorders.</p><p><strong>Objective: </strong>This study aims to explore survivin behaviour in SLE patients with lupus nephritis (LN), assessing its potential as a therapeutic and prognostic biomarker.</p><p><strong>Methods: </strong>297 SLE patients were classified based on the American College of Rheumatology (ACR) 1997 criteria, from 2000 to 2015. In a cross-sectional study, the serum level of survivin was measured by an ELISA test and compared between 200 SLE individuals and healthy controls. In a longitudinal cohort, 97 patients with active LN had the concentration of survinin measured, before and after treatment with cyclophosphamide pulse therapy.</p><p><strong>Results: </strong>The serum concentration of survivin was significantly lower in the SLE group than in healthy controls, regardless of concomitant NL or disease activity. The longitudinal evaluation revealed a significant reduction in survivin serum level after treatment. However, survivin rates were not able to discriminate groups that achieved remission from those that maintained nephritis activity.</p><p><strong>Conclusion: </strong>Our study suggests that survivin levels in SLE patients are lower than in the general population. Even so, its use as a biomarker in SLE seems limited, not reflecting disease activity or response to LN treatment, as in other contexts.</p>","PeriodicalId":47060,"journal":{"name":"Biomarker Insights","volume":" ","pages":"11772719221131470"},"PeriodicalIF":3.8,"publicationDate":"2022-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d0/ea/10.1177_11772719221131470.PMC9597205.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40656300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}